I just don't see any way that an approval happens in 2027. Not with such a large trial.
Even if enrollment begins Q3, it will take time for all locations to come online because each hospitals internal review board has to approve the trial. As we saw with the EFS, that takes longer some hospitals.
Then I think a year and a half is a reasonable earliest time frame to complete enrollment. Just my somewhat educated guess and it could take longer.
Patients will be followed for a year after being implanted so the trial won't be complete until a year after the last patient is implanted.
Then probably another 3-4 months to finalize everything and submit it to the FDA.
And finally the FDA will have 180 days to hand down their decision, although they can stop the clock on that if there are issues with manufacturing or something, which I don't expect but it is possible.
So my earliest timeframe is a PMA in late 2028 but we know that almost everything takes longer than expected. I am, as always, just a guy on the internet so my opinions are not gospel though.
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